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Argon Medical Devices, Inc
Argon Medical Devices, Inc: 48 FDA recall reports
Every medical device recall the FDA has published for Argon Medical Devices, Inc. The fault, and how the agency graded it.
48Reports
8Class I
13Ongoing
2026-07-22Most recent
8 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
General Biospy Tray, REF: GUTS1000
Z-2706-2026 · Class I · reported 2026-07-22 · Ongoing
- Why it was recalled
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Product
- General Biospy Tray, REF: GUTS1000
- Where it went
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- How much
- 1800
Class I
Arterial Line Kit 20ga x 6, REF: 400115A
Z-2708-2026 · Class I · reported 2026-07-22 · Ongoing
- Why it was recalled
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Product
- Arterial Line Kit 20ga x 6, REF: 400115A
- Where it went
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- How much
- 440
Class I
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Z-2704-2026 · Class I · reported 2026-07-22 · Ongoing
- Why it was recalled
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Product
- Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
- Where it went
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- How much
- 950
Class I
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Z-2705-2026 · Class I · reported 2026-07-22 · Ongoing
- Why it was recalled
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Product
- One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- Where it went
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- How much
- 200
Class I
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Z-2707-2026 · Class I · reported 2026-07-22 · Ongoing
- Why it was recalled
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Product
- T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
- Where it went
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- How much
- 850
Class I
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Z-2709-2026 · Class I · reported 2026-07-22 · Ongoing
- Why it was recalled
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Product
- Bone Marrow Tray, REF: CB0033TL; CB0355TLA
- Where it went
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- How much
- 680
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter i
Z-0589-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
- Product
- Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
- Where it went
- U.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S. (international) to countries of: China, Panama and Trinidad and Tobago
- How much
- Total devices 1821 (US=1794 and O.U.S.=27) units
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-
Z-3192-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
- Product
- BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X
- Where it went
- Worldwide - US Nationwide distribution including in the states of AZ, FL, OH, NY, MO, CO, IL, NC, CA, AK, PA, MN, ND, TX, SC, AR, WI, OK, TN, KS, UT, NJ, VA, MA, KY, IN, AL, DE, MT, NE, WV, NV, HI, OR, WA, NH, LA, CT, MI, GA, MD, ID, MS, IA, RI, NM, VT and the countries of ITA, TUN, ROU, LTU, BEL, GBR, CAN, TUR, POL, PAN, THA, PRT, TWN, AUT, NZL, AUS, BGR, MEX, CHE, NLD, PHL, PER, FRA, SGP, ZAF, CZE, EST, ESP, OMN, NPL, COL, PRI, ISR, JPN, KEN, BHR, ARE, CHN.
- How much
- 95,430
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Z-2638-2024 · Class II · reported 2024-08-21 · Ongoing
- Why it was recalled
- Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
- Product
- L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
- Where it went
- US distribution to the states of: TX, WA, CA, IL
- How much
- 155
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femor
Z-2239-2023 · Class II · reported 2023-08-02 · Ongoing
- Why it was recalled
- There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
- Product
- Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
- Where it went
- US Nationwide distribution in the state of TX.
- How much
- 3.0
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Z-0563-2022 · Class II · reported 2022-02-16 · Ongoing
- Why it was recalled
- Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
- Product
- 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
- Where it went
- US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
- How much
- 600 ea
SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114
Z-0354-2022 · Class II · reported 2021-12-15 · Ongoing
- Why it was recalled
- Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
- Product
- SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; 701114150M/SUPERCORE BIOPSY INSTR 14GA X...
- Where it went
- Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of ALB, ARE, ARG, AUS, AUT, BEL, BGD, BRA, CAN, CHE, CHL, CHN, COL, CZE, DEU, ECU, ESP, EST, FRA, GBR, GRC, HKG, HUN, IND, IRN, ISR, ITA, JOR, JPN, MAR, MEX, MYS, NLD, NPL, NZL, PAK, PER, PHL, POL, PRT, SAU, SGP, SRB, THA, TUR, and TWN.
- How much
- 79,910 devices
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp pun
Z-2501-2021 · Class II · reported 2021-09-29 · Ongoing
- Why it was recalled
- As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
- Product
- Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
- Where it went
- U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
- How much
- 20 units
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle,
Z-1076-2021 · Class II · reported 2021-02-17 · Terminated
- Why it was recalled
- Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
- Where it went
- US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
- How much
- 1759 units
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle,
Z-1075-2021 · Class II · reported 2021-02-17 · Terminated
- Why it was recalled
- Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
- Where it went
- US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
- How much
- 247 units
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle,
Z-1073-2021 · Class II · reported 2021-02-17 · Terminated
- Why it was recalled
- Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
- Where it went
- US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
- How much
- 863 unit
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle,
Z-1077-2021 · Class II · reported 2021-02-17 · Terminated
- Why it was recalled
- Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
- Where it went
- US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
- How much
- 583 units
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle,
Z-1074-2021 · Class II · reported 2021-02-17 · Terminated
- Why it was recalled
- Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
- Where it went
- US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
- How much
- 187 units
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle,
Z-1072-2021 · Class II · reported 2021-02-17 · Terminated
- Why it was recalled
- Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
- Product
- Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,
- Where it went
- US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
- How much
- 483 units
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usa
Z-2806-2020 · Class II · reported 2020-08-26 · Terminated
- Why it was recalled
- Sterile introducer sheath set manufactured under one lot with different expiration dates.
- Product
- ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
- Where it went
- US Nationwide distribution including in the state of MS.
- How much
- 1000 units
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS -
Z-2427-2020 · Class II · reported 2020-07-01 · Terminated
- Why it was recalled
- Incorrect product labeling.
- Product
- BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.
- Where it went
- Worldwide distribution - US Nationwide including in the states of TX, IL, FL, KS, MD, CA, WA, NY, WI, PA and the countries of United Arab Emirates (Dubai), Spain, Canada.
- How much
- 165 units in U.S. and 330 units Internationally
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product
Z-2109-2020 · Class II · reported 2020-06-03 · Terminated
- Why it was recalled
- Tungsten coils of the guidewire included in the introducer kit were detaching.
- Product
- Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.
- Where it went
- International distribution to the countries of China, Taiwan.
- How much
- 15,795 units
PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage
Z-1938-2020 · Class II · reported 2020-05-20 · Terminated
- Why it was recalled
- Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
- Product
- PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for contralateral access to the iliac artery and selected vasculature. Case Label: PAC Tray/5 Catheter Introducer Tray 8F, QTY 10/Bx, Rx Only, STERILE EO
- Where it went
- US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
- How much
- 80
Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial
Z-1937-2020 · Class II · reported 2020-05-20 · Terminated
- Why it was recalled
- Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
- Product
- Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit/1 20ga x 3", Qty: 10/CS, CE 2797
- Where it went
- US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
- How much
- 20
Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arteria
Z-1936-2020 · Class II · reported 2020-05-20 · Terminated
- Why it was recalled
- Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
- Product
- Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit 20ga x 3", Ref 498411B, Qty: 10/CS
- Where it went
- US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
- How much
- 150
Class I
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly
Z-1792-2020 · Class I · reported 2020-05-13 · Terminated
- Why it was recalled
- The stiffness of the soft end of the guidewire caused tissue perforation.
- Product
- 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
- Where it went
- No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
- How much
- 1190 units
Class I
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly
Z-1791-2020 · Class I · reported 2020-05-13 · Terminated
- Why it was recalled
- The stiffness of the soft end of the guidewire caused tissue perforation.
- Product
- 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
- Where it went
- No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
- How much
- 1690 units
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/packa
Z-0293-2020 · Class II · reported 2019-11-13 · Terminated
- Why it was recalled
- The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- Product
- (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Where it went
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
- How much
- Total number in recall for all products in dist: 49,130 units
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, St
Z-0291-2020 · Class II · reported 2019-11-13 · Terminated
- Why it was recalled
- The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- Product
- Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Where it went
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
- How much
- Total number in recall for all products in dist: 49,130 units
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, RE
Z-0288-2020 · Class II · reported 2019-11-13 · Terminated
- Why it was recalled
- The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- Product
- (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.
- Where it went
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
- How much
- Total number in recall for all products in dist: 49,130 units
Showing the 30 most recent of 48. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls